Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KAI Pharmaceuticals
• Collaborator: Trident Clinical Research Pty Ltd
• Treatments: Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• American Society of Anesthesiologist (ASA) classification 1, 2, or 3

• total hip or total knee replacement

• pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)

Exclusion Criteria:

• presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment

• recent history of angina or myocardial infarction (MI)

• clinically significant abnormality on laboratory tests or electrocardiogram (ECG)